The Case for the Use of Patient and Caregiver Perception of Change Assessments in Rare Disease Clinical Trials: A Methodologic Overview
ConclusionCapturing patient experience data with sufficient rigor allows it to contribute to the body of evidence utilized in regulatory, payer, and prescriber decision-making. Adding PPC and CPC Assessments to rare disease clinical trials offers an innovative and powerful way to tap into the unique insights of patients and their families to develop a fuller picture of the patient experience in the clinical trial.FundingStealth BioTherapeutics Inc. (Source: Advances in Therapy)
Source: Advances in Therapy - March 16, 2019 Category: Drugs & Pharmacology Source Type: research

Thyroid Cancer Benefits the Prognosis of Ovarian Cancer: A SEER-Based Study
AbstractIntroductionTo explore the effect of a second thyroid cancer (TC) on ovarian cancer (OC) patient survival, we compared OC patients with or without a second primary TC using data from the Surveillance, Epidemiology, and End Results (SEER) database.MethodsData for OC only, female TC only and OC patients with a second TC (OC2TC) from two periods, 2000 –2014 and 1980–1994, were extracted from the SEER database. Differences in clinicopathological and treatment characteristics were analysed using the chi-square test. Cox regression analyses were used to identify risk factors associated with OC survival. Disea...
Source: Advances in Therapy - March 16, 2019 Category: Drugs & Pharmacology Source Type: research

Bloating and Abdominal Distension: Clinical Approach and Management
AbstractFunctional abdominal bloating and distension (FABD) are common gastrointestinal complaints, encountered on a daily basis by gastroenterologists and healthcare providers. Functional abdominal bloating is a subjective sensation that is commonly associated with an objective abdominal distension. FABD may be diagnosed as a single entity (the sole or cardinal complaint) or may overlap with other functional gastrointestinal disorders such as functional constipation, irritable bowel syndrome, and functional dyspepsia. The pathophysiology of FABD is not completely understood. Proposed underlying mechanisms include visceral...
Source: Advances in Therapy - March 16, 2019 Category: Drugs & Pharmacology Source Type: research

Assessing the Role of Anti rh-GAA in Modulating Response to ERT in a Late-Onset Pompe Disease Cohort from the Italian GSDII Study Group
AbstractIntroductionPatients with late-onset Pompe disease (LOPD) receiving enzyme replacement therapy (ERT) may develop IgG antibodies against alglucosidase alpha (anti-rhGAA) in the first 3  months of treatment. The exact role of these antibodies in modulating efficacy of ERT in this group of patients is still not fully understood. To assess whether anti rh-GAA antibodies interfere with ERT efficacy, we studied a large Italian cohort of LOPD patients.MethodsWe analyzed clinical findings and performed serial measurements of IgG anti rh-GAA antibody titers from 64 LOPD patients treated with ERT. The first examination ...
Source: Advances in Therapy - March 16, 2019 Category: Drugs & Pharmacology Source Type: research

Efficacy of Chondroitin Sulfate in Patients with Knee Osteoarthritis: A Comprehensive Meta-Analysis Exploring Inconsistencies in Randomized, Placebo-Controlled Trials
The objective of this study was to determine whether CS is effective at alleviating pain and improving function in patients with knee OA and to identify the factors that explain inconsistencies in clinical trial results.MethodsWe conducted a systematic review of randomized, placebo-controlled trials, searching the databases Medline, Cochrane central register for controlled trials and Scopus. Random effects meta-analysis was then performed, using tau2 andI2 statistics to assess heterogeneity. The pain and Lequesne index (LI) scores were expressed as standardized mean differences (SMDs), with a 95% confidence interval (CI). ...
Source: Advances in Therapy - March 16, 2019 Category: Drugs & Pharmacology Source Type: research

Long-Term Effects and Adverse Events of Nintedanib Therapy in Idiopathic Pulmonary Fibrosis Patients with Functionally Advanced Disease
AbstractIntroductionIdiopathic pulmonary fibrosis (IPF) is one of the most common interstitial lung diseases with limited survival. The effect of IPF therapy in patients with severely impaired lung function is not well established. The aim of this study was to characterize IPF patients with a forced vital capacity (FVC)  
Source: Advances in Therapy - March 14, 2019 Category: Drugs & Pharmacology Source Type: research

A Relative Cost of Control Analysis of Once-Weekly Semaglutide Versus Exenatide Extended-Release and Dulaglutide for Bringing Patients to HbA1c and Weight Loss Treatment Targets in the USA
AbstractIntroductionThe SUSTAIN 3 and 7 clinical trials compared the efficacy and safety of once-weekly semaglutide relative to exenatide extended-release (ER) and dulaglutide, respectively, in the treatment of patients with type 2 diabetes (T2D). The trials included a series of clinically relevant single and composite endpoints focused on improving glycemic control and reducing body weight, while avoiding hypoglycemia. The present study combined SUSTAIN 3 and 7 outcomes with short-term treatment costs to evaluate the relative cost of control of once-weekly semaglutide versus exenatide ER and dulaglutide.MethodsProportions...
Source: Advances in Therapy - March 14, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Safety and Efficacy of Ripasudil in Japanese Patients with Glaucoma or Ocular Hypertension: 3-month Interim Analysis of ROCK-J, a Post-Marketing Surveillance Study
In the original publication values in the results section are incorrect. Errors were also identified in Fig.  5 (Source: Advances in Therapy)
Source: Advances in Therapy - March 13, 2019 Category: Drugs & Pharmacology Source Type: research

Biomarkers in Non-Small Cell Lung Cancers: Indian Consensus Guidelines for Molecular Testing
AbstractNovel molecular targets and promising targeted therapies have reshaped diagnostics in patients with advanced non-small cell lung cancer (NSCLC). Despite this progress, the implementation of molecular screening to identify predictive biomarkers in Indian clinical and pathology settings has been challenging due to operational and logistical constraints. This consensus guideline brings together medical oncologists, molecular pathologists and pathologists from India to provide a quick and competent reference for biomarker testing in NSCLC. The guideline summarizes the importance of targetable mutations in NSCLC such as...
Source: Advances in Therapy - March 12, 2019 Category: Drugs & Pharmacology Source Type: research

Indirect Treatment Comparison of the Efficacy and Safety of Sarilumab Monotherapy in Rheumatoid Arthritis Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs
AbstractIntroductionTo evaluate the comparative efficacy and safety of subcutaneous sarilumab 200  mg monotherapy administered every 2 weeks (q2w) versus other monotherapies of biologic, targeted and conventional synthetic disease-modifying antirheumatic drugs (bDMARDs, tsDMARDs, csDMARDs) at recommended doses for treatment of rheumatoid arthritis in patients who are intolerant of or inadequat e responders to csDMARDs (csDMARD-IR).MethodsA systematic literature review and network meta-analysis (NMA) were conducted on 24-week efficacy outcomes: Health Assessment Questionnaire Disability Index (HAQ-DI) score, Ameri...
Source: Advances in Therapy - March 12, 2019 Category: Drugs & Pharmacology Source Type: research

Accurate Estrogen Receptor Quantification in Patients with Negative and Low-Positive Estrogen-Receptor-Expressing Breast Tumors: Sub-Analyses of Data from Two Clinical Studies
ConclusionsRT-PCR provided a more accurate assessment of ER expression in patients with ER-low+ tumors, and data support dual testing for patients with ER-low+ status to ensure appropriate treatment planning as it pertains to endocrine therapy.FundingGenomic Health, Inc. (Source: Advances in Therapy)
Source: Advances in Therapy - March 11, 2019 Category: Drugs & Pharmacology Source Type: research

A Critical Overview of the Biological Effects of Mitomycin  C Application on the Cornea Following Refractive Surgery
This article critically reviews the available evidence on the biological effects, safety, and clinical benefits of the off-label use of MMC in corneal refractive surgery. (Source: Advances in Therapy)
Source: Advances in Therapy - March 11, 2019 Category: Drugs & Pharmacology Source Type: research

The Role of Glucagon-Like Peptide-1 Receptor Agonists in Type 2 Diabetes in Asia
In conclusion, GLP-1RAs, especially short-acting GLP-1RAs, are a practical treatment option for East Asian patients with T2D inadequately controlled by OADs or basal insulin.Funding: Sanofi. (Source: Advances in Therapy)
Source: Advances in Therapy - March 11, 2019 Category: Drugs & Pharmacology Source Type: research

Patient Needs, Perceptions, and Attitudinal Drivers Associated with Obesity: A Qualitative Online Bulletin Board Study
ConclusionsAs losing excess weight is a challenge for most overweight individuals, the qualitative insights from this OBB can inform the planning and successful execution of various weight management and drug development programs.FundingNovartis Pharma AG, Basel Switzerland. (Source: Advances in Therapy)
Source: Advances in Therapy - March 11, 2019 Category: Drugs & Pharmacology Source Type: research

Factors Associated with the Initiation of Long-Acting Injectable Paliperidone Palmitate Versus Aripiprazole Among Medicaid Patients with Schizophrenia: An Observational Study
This study investigated variables associated with initiation of treatment with the long-acting injectables paliperidone palmitate (LAI-PP) and aripiprazole LAI (LAI-AP) in Medicaid patients with schizophrenia.MethodsAdults with at least one medical or pharmacy claim for LAI-PP or LAI-AP from 1 January 2013 to 31 December 2016 were selected from the IBM® MarketScan® Medicaid Database. The date of the first LAI-PP or LAI-AP claim was the index date. Patients who had at least two medical claims, on different days, for a schizophrenia diagnosis and at least 12  months of continuous health plan enrollment prior to ...
Source: Advances in Therapy - March 8, 2019 Category: Drugs & Pharmacology Source Type: research

Clinician Concepts of Cure in Adult Relapsed and Refractory Philadelphia-Negative B Cell Precursor Acute Lymphoblastic Leukemia: A Delphi Study
ConclusionsAlthough such terminology remains contested, clinicians would begin considering “cure” as early as 2 years provided the patient is off therapy, with most considering the term applicable by the third year.FundingAmgen Inc. (Source: Advances in Therapy)
Source: Advances in Therapy - March 7, 2019 Category: Drugs & Pharmacology Source Type: research

Dose Determination for a Fixed-Dose Drug Combination: A Phase II Randomized Controlled Trial for Tiotropium/Olodaterol Versus Tiotropium in Patients with COPD
AbstractIntroductionDuring the clinical development of a fixed-dose combination of drugs, it is best practice to conduct dose-finding studies to determine the optimal dose of each component. The aims of this phase II dose-finding study were to confirm the lung function benefit of adding olodaterol to tiotropium, describe the dose –response relationship of olodaterol in combination with tiotropium 5 μg, and compare it with the dose response of olodaterol monotherapy.MethodsIn this double-blind, parallel-group trial, patients were randomized to receive either tiotropium 5  μg or a fixed-dose combin...
Source: Advances in Therapy - March 6, 2019 Category: Drugs & Pharmacology Source Type: research

Profile of Women Initiated on Denosumab and Pattern of Use in a Restricted Postmenopausal Osteoporosis Indication: A French Database Analysis Over the Period 2013 –2014
ConclusionThis study suggests satisfactory compliance of prescribers concerning the restriction of the reimbursed indication of denosumab in second line after bisphosphonates with 6.2% possible inappropriate prescriptions.FundingAmgen. (Source: Advances in Therapy)
Source: Advances in Therapy - March 5, 2019 Category: Drugs & Pharmacology Source Type: research

Case Series of Combined iStent Implantation and Phacoemulsification in Eyes with Primary Angle Closure Disease: One-Year Outcomes
AbstractPurposeTo evaluate the safety and efficacy of combined iStent ® trabecular micro-bypass device (Glaukos, Laguna Hills, CA) and phacoemulsification in eyes with primary angle closure disease.MethodsA two-center prospective interventional case series of consecutive patients with primary angle closure (PAC) or primary angle closure glaucoma (PACG) on at least one glaucoma medication, who underwent iStent implantation with cataract surgery. Postoperatively, patients were assessed on days 1 and 7, and months 1, 3, 6, and 12. The intraocular pressure (IOP), glaucoma medication use, visual acuity, and the presence of ...
Source: Advances in Therapy - February 28, 2019 Category: Drugs & Pharmacology Source Type: research

Haptoglobin 2-2 Genotype is Associated with More Advanced Disease in Subjects with Non-Alcoholic Steatohepatitis: A Retrospective Study
This study aimed to investigate the association between Hp gene polymorphism and the severity of nonalcoholic fatty liver disease (NAFLD).MethodsA total of 441 subjects (NAFLD group,n = 272; healthy control,n = 169) were recruited, and their clinical biochemical parameters were measured in all subjects. Haptoglobin genotyping was performed using genomic DNA extracted from peripheral blood leukocytes. Among the NAFLD group, 107 patients underwent liver biopsy, and histology was evaluated by a patholo gist on the basis of the CRN scoring system.ResultsNAFLD patients had much lower frequency of Hp ...
Source: Advances in Therapy - February 28, 2019 Category: Drugs & Pharmacology Source Type: research

Real-World Treatment Patterns Among Patients Initiating Small Molecule Kinase Inhibitor Therapies for Thyroid Cancer in the United States
ConclusionSorafenib was the most common first-line agent during 2010 –2014 but was supplanted by lenvatinib starting in 2015. Approximately 36–53% of patients received a second-line treatment. Median treatment duration results suggested potential benefit of SMKI in second-line therapy. SMKI treatment after first-line failure may be considered for appropriately se lected patients.FundingEisai, Inc. (Woodcliff Lake, NJ). (Source: Advances in Therapy)
Source: Advances in Therapy - February 28, 2019 Category: Drugs & Pharmacology Source Type: research

Multidisciplinary Management of Psoriatic Arthritis: The Benefits of a Comprehensive Approach
AbstractPsoriatic arthritis (PsA) is a lifelong disease associated with extra-articular manifestations and several comorbidities, as well as reduced quality of life and psychosocial burden. Diagnostic delay is associated with poorer outcomes, while a short delay between symptom onset and diagnosis is linked with preservation of function. Overcoming the barriers to early diagnosis of PsA is often difficult to achieve in the absence of well-characterized disease markers and/or a definitive screening procedure. Once a diagnosis is made, approaches to care may differ between countries, but a treat-to-target approach can be adv...
Source: Advances in Therapy - February 25, 2019 Category: Drugs & Pharmacology Source Type: research

Enhancement of Retinal Function and of Neural Conduction Along the Visual Pathway Induced by Treatment with Citicoline Eye Drops in Liposomal Formulation in Open Angle Glaucoma: A Pilot Electrofunctional Study
AbstractIntroductionTo evaluate the retinal function and the relative neural conduction along the visual pathway after treatment with citicoline in liposomal formulation (CLF) eye drops in patients with open angle glaucoma (OAG).MethodsTwelve OAG patients (mean age  ± standard deviation 52.58 ± 11.39 years, intraocular pressure 
Source: Advances in Therapy - February 21, 2019 Category: Drugs & Pharmacology Source Type: research

Claros System: A Rapid Microfluidics-Based Point-of-Care System for Quantitative Prostate Specific Antigen Analysis from Finger-Stick Blood
ConclusionThe Claros1® PSA assay combines the advantages of rapid, accurate detection with a low required sample volume, allowing the analysis to be performed using finger-stick blood. Provided that further analysis proves the reproducibility of the test, it may help to reduce the number of office visits, thus decreasing costs to the health care system. (Source: Advances in Therapy)
Source: Advances in Therapy - February 18, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Effectiveness of Ipragliflozin for Type 2 Diabetes in Japan: 12-Month Interim Results of the STELLA-LONG TERM Post-Marketing Surveillance Study
AbstractIntroductionThe present interim report of the STELLA-LONG TERM study aimed to examine the safety and effectiveness of ipragliflozin in real-word clinical practice in Japan using data up to 12  months. We also evaluated the effect of ipragliflozin on aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels in patients with normal vs. abnormal liver function.MethodsThis is an ongoing 3-year post-marketing surveillance study. We analyzed data from Japanese type 2 diabetes mellitus (T2DM) patients who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015 at participating ce...
Source: Advances in Therapy - February 14, 2019 Category: Drugs & Pharmacology Source Type: research

Clinical Management of High and Very High Risk Patients with Hyperlipidaemia in Central and Eastern Europe: An Observational Study
AbstractIntroductionA retrospective/prospective observational study was conducted to explore the current management of hyperlipidaemia in high-risk (HR) and very high risk (VHR) patients in central/eastern Europe and Israel.MethodsThe study enrolled adult patients who were receiving lipid-lowering therapy and attending a specialist (cardiologist/diabetologist/lipidologist) or internist for a routine visit at 57 sites (including academic/specialist/internal medicine centres) across Bulgaria, Croatia, Czech Republic, Israel, Poland, Romania and Slovakia. Data were collected from medical records, for the 12  months befor...
Source: Advances in Therapy - February 13, 2019 Category: Drugs & Pharmacology Source Type: research

Effect of Caffeine on the Bioavailability and Pharmacokinetics of an Acetylsalicylic Acid-Paracetamol Combination: Results of a Phase I Study
ConclusionCaffeine did not affect the pharmacokinetics of ASA and paracetamol when used as an adjuvant in ASA/paracetamol fixed-dose combination under fasting conditions, suggesting that caffeine enhances the analgesic efficacy of these drugs by pharmacodynamic rather than pharmacokinetic interactions.FundingSanofi-Aventis Deutschland GmbH. (Source: Advances in Therapy)
Source: Advances in Therapy - February 13, 2019 Category: Drugs & Pharmacology Source Type: research

Micronized Purified Flavonoid Fraction (MPFF) for Patients Suffering from Chronic Venous Disease: A Review of New Evidence
AbstractChronic venous disease (CVD) is both prevalent and unavoidable in many people as a result of persistent or unalterable risk factors, the most important of which are advanced age, excess body weight, and family history. Given this inevitability, medical treatment is required to alleviate symptoms and slow disease progression. Venoactive drug therapy is emerging as a valuable treatment option for many CVD patients and micronized purified flavonoid fraction (MPFF) is the most widely prescribed and well-studied venoactive drug available. Recent evidence from animal models of venous hypertension and from clinical trials...
Source: Advances in Therapy - February 13, 2019 Category: Drugs & Pharmacology Source Type: research

The Seriousness of Chronic Venous Disease: A Review of Real-World Evidence
AbstractChronic venous disease (CVD) is a prevalent condition that tends to worsen with age. Patients initially seek treatment to relieve symptoms of leg pain, discomfort, heaviness and swelling, all of which impact their quality of life. As the disease increases in severity to include varicose veins, skin changes, and venous ulcer, the demand for treatment increases while the quality of life further diminishes. The prevalence of CVD is highest in Western countries where it already consumes up to 2% of healthcare budgets. With the aging of the global population, the prevalences of CVD and severe CVD are projected to increa...
Source: Advances in Therapy - February 13, 2019 Category: Drugs & Pharmacology Source Type: research

The Progressive Multifocal Leukoencephalopathy Consortium as a Model for Advancing Research and Dialogue on Rare Severe Adverse Drug Reactions
AbstractProgressive multifocal leukoencephalopathy (PML) is a rare but serious disease. Caused by the JC virus (JCV), it occurs in individuals with weakened immune systems and is a potential adverse reaction for certain immunomodulatory drugs. The PML Consortium was created to find better methods to predict, prevent, and treat PML. The Consortium brought together the pharmaceutical industry with academic, regulatory, and patient communities to advance research and dialogue on PML through a not-for-profit, collaborative approach involving a grant program, scientific workshops and conferences, and disease awareness efforts. ...
Source: Advances in Therapy - February 13, 2019 Category: Drugs & Pharmacology Source Type: research

The Association Between Type 2 Diabetes and Cardiovascular Disease: The “For Your SweetHeart™” Survey
ConclusionsFindings indicate that education regarding the association between T2DM and CVD in patients and their loved ones is warranted.Plain Language SummaryPlain language summary available for this article. Please see Fig. 1 and the following link:https://doi.org/10.6084/m9.figshare.7546817.FundingThe “For Your SweetHeart™” survey was supported by the Boehringer Ingelheim& Eli Lilly and Company Diabetes Alliance, and was developed in partnership with KRC Research. (Source: Advances in Therapy)
Source: Advances in Therapy - February 13, 2019 Category: Drugs & Pharmacology Source Type: research

Matching-Adjusted Indirect Comparison of Blinatumomab vs. Inotuzumab Ozogamicin for Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia
ConclusionsAfter adjusting for cross-trial differences, blinatumomab demonstrated a similar CR rate and potential OS benefit versus InO among adult patients with R/R ALL who received no more than one prior salvage therapy. Further studies are suggested to confirm this finding.FundingAmgen. (Source: Advances in Therapy)
Source: Advances in Therapy - February 13, 2019 Category: Drugs & Pharmacology Source Type: research

How Does Chronic Venous Disease Progress from the First Symptoms to the Advanced Stages? A Review
AbstractRisk factors for the development of progression chronic venous disease (CVD) and varicose veins are widespread and include advanced age, excess body weight, sedentary lifestyles and occupations, family history, and pregnancy. Varicose veins and CVD are associated with venous hypertension, venous reflux, dysfunctional venous valves, and vein wall inflammation, though the precise etiologies are unclear. Once venous pathology develops, it can progress through a vicious cycle of inflammation and leukocyte recruitment that leads to further deterioration of vein walls and valves, increased hypertension, and release of ad...
Source: Advances in Therapy - February 13, 2019 Category: Drugs & Pharmacology Source Type: research

Burden and Suffering in Chronic Venous Disease
AbstractChronic venous disease (CVD) is widespread, underdiagnosed, and can progress to chronic venous insufficiency and venous ulcers, which can require extensive treatment and hospitalization. These conditions negatively impact patient quality of life and place substantial burdens on healthcare resources. The two main risk factors for CVD are age and obesity. Thus, with the growing prevalence of obesity and the increasing longevity of the population, the burden of CVD is expected to increase dramatically in the coming decades. Appropriate lifestyle changes and care, which may include treatment with venoactive drugs, can ...
Source: Advances in Therapy - February 13, 2019 Category: Drugs & Pharmacology Source Type: research

Fixed-Dose Combinations of Long-Acting Bronchodilators for the Management of COPD: Global and Asian Perspectives
AbstractMaintenance bronchodilator therapy with long-acting β-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) is the cornerstone treatment for patients with stable chronic obstructive pulmonary disease (COPD). Fixed-dose combinations (FDCs) of LABA/LAMA are recommended for the majority of symptomatic COPD patients by global guidelines; regio nal guidelines such as the Japanese and Korean guidelines also provide similar recommendations for the use of LABA/LAMA FDCs. This review comprehensively describes the latest clinical evidence from key studies on the efficacy and safety of four approved LABA/LAMA f...
Source: Advances in Therapy - February 11, 2019 Category: Drugs & Pharmacology Source Type: research

Insights on Medical Nutrition Therapy for Type 2 Diabetes Mellitus: An Indian Perspective
AbstractIt is critical to integrate medical nutrition therapy (MNT) provided by a registered dietician (RD) into primary care of type 2 diabetes mellitus (T2DM). This is necessary to achieve the goals of improving overall metabolic measures beyond calorie restriction and weight loss. Misconceptions about nutrition in T2DM add to the challenges of executing MNT in a culturally sensitive population. The current review provides insights into MNT for the prevention and management of T2DM in India, based on both evidence and experience. It revisits historical Indian studies and provides information on appropriate dietary intake...
Source: Advances in Therapy - February 7, 2019 Category: Drugs & Pharmacology Source Type: research

Subgroup Analysis for Chinese Patients Included in the INPULSIS ® Trials on Nintedanib in Idiopathic Pulmonary Fibrosis
ConclusionsNintedanib is clinically efficacious in Chinese patients with IPF with approximately 50% reductions in the rate of decline in FVC, demonstrating slowed disease progression. Similar to the overall INPULSIS® population, nintedanib has a favourable benefit/risk profile in Chinese patients with IPF.ClinicalTrials.gov identifiersNCT01335464, NCT01335477.FundingBoehringer Ingelheim.Plain Language SummaryPlain language summary available for this article. (Source: Advances in Therapy)
Source: Advances in Therapy - February 7, 2019 Category: Drugs & Pharmacology Source Type: research

Intravitreal Ranibizumab for the Treatment of Visual Impairment Due to Choroidal Neovascularization Associated with Rare Diseases: Cost-Effectiveness in the UK
ConclusionIntravitreal ranibizumab is a highly cost-effective intervention for the treatment of CNV due to causes other than nAMD and PM as it delivers substantial QALY gains to patients while making cost savings vs. BSC.FundingNovartis Pharmaceuticals UK Ltd. (Source: Advances in Therapy)
Source: Advances in Therapy - February 6, 2019 Category: Drugs & Pharmacology Source Type: research

SOFA Score Can Effectively Predict the Incidence of Sepsis and 30-Day Mortality in Liver Transplant Patients: A Retrospective Study
This study aims to evaluate the early predictive value for postoperative sepsis and 30-day mortality in liver transplant patients using sequential organ failure assessment (SOFA).MethodsA total of 96 liver transplant patients were enrolled into this study from February 2015 to June 2018. The general information, biochemical findings, and postoperative 30-day mortality of these patients were statistically analyzed.ResultsThe SOFA scores, C-reactive protein (CRP), and procalcitonin (PCT) at postoperative day (POD) 3, 5, and 7 were significantly higher in the sepsis group than in the non-sepsis group, and the differences were...
Source: Advances in Therapy - February 5, 2019 Category: Drugs & Pharmacology Source Type: research

Characterizing the Health-Related Quality of Life Burden of Overactive Bladder Using Disease-Specific Patient-Reported Outcome Measures: A Systematic Literature Review
ConclusionThe HRQoL burden of OAB and response to treatment can be reliably measured by PRO instruments, and the OAB-q is the most commonly used instrument in OAB, particularly in clinical trials of OAB interventions. These data will be useful to provide benchmarks of burden levels for PRO scores obtained among those on contemporary therapies for comparison with outcomes from patients managed with emerging treatments.FundingAstellas Pharma Global Development, Inc. (Source: Advances in Therapy)
Source: Advances in Therapy - February 4, 2019 Category: Drugs & Pharmacology Source Type: research

Safety Profile of HTX-019 Administered as an Intravenous Push in Cancer Patients: A Retrospective Review
ConclusionThis is  the first study to demonstrate that HTX-019 can be safely administered via IV push in patients with cancer receiving emetogenic chemotherapy while negating the need for fluid bags, which are scarce.FundingHeron Therapeutics, Inc., San Diego, CA, USA.Plain Language SummaryPlain language summary available for this article. (Source: Advances in Therapy)
Source: Advances in Therapy - January 31, 2019 Category: Drugs & Pharmacology Source Type: research

Physical and Chemical Compatibility of Extended-Release Triamcinolone Acetonide (TA-ER) with Common Local Anesthetics
ConclusionThese results demonstrate that lidocaine, bupivacaine, and ropivacaine are physically and chemically compatible with TA-ER, suggesting that local anesthetic solutions can be added to TA-ER preparations in clinical practice without adversely affecting TA-ER in vitro product characteristics.FundingFlexion Therapeutics, Inc. (Source: Advances in Therapy)
Source: Advances in Therapy - January 31, 2019 Category: Drugs & Pharmacology Source Type: research

Unmet Clinical Need in the Management of Locally Advanced Unresectable Lung Cancer: Treatment Strategies to Improve Patient Outcomes
AbstractStage III locally advanced non-small cell lung cancer (LA NSCLC) comprises the most heterogeneous group of patients, accounts for one-third of patients with lung cancer, and is unresectable at presentation. Multiple treatment approaches have evolved over the past few decades focusing on timing of chemoradiation (concurrent vs. sequential) and sequencing of therapy (induction vs. consolidation). Concurrent chemoradiation (CCRT) emerged as the standard of care for the majority of the patients worldwide. Despite improvements in median and overall survival (OS) using the concurrent approach, the rate of distant failure...
Source: Advances in Therapy - January 29, 2019 Category: Drugs & Pharmacology Source Type: research

Prospective Observational Cohort Study to Describe the Use of Panitumumab in Combination with Chemotherapy in Real-World Clinical Practice for Patients with Wild-Type RAS mCRC
ConclusionOverall, the study results show that treatment patterns, clinical efficacy, and the safety profile of panitumumab in routine clinical practice were comparable to those in randomized controlled trials. The relatively low skin toxicity rate could be attributed to increasing experience in managing panitumumab-associated rash and some degree of underreporting.FundingAmgen. (Source: Advances in Therapy)
Source: Advances in Therapy - January 28, 2019 Category: Drugs & Pharmacology Source Type: research

Posttraumatic Arterial Priapism Treated with Superselective Embolization: Our Clinical Experience and a Review of the Literature
ConclusionSuperselective embolization of the fistula is an effective option for arterial priapism. Absorbable agents should be used. Superselective arterial embolization should be considered after 3  weeks of conservative treatment. Patients should undergo another 3 weeks of “observation” treatment before repeated intervention. (Source: Advances in Therapy)
Source: Advances in Therapy - January 25, 2019 Category: Drugs & Pharmacology Source Type: research

Real-World Postmarketing Study of the Impact of Adalimumab Treatment on Work Productivity and Activity Impairment in Patients with Psoriatic Arthritis
This study investigated the effectiveness of adalimumab treatment in improving Work Productivity and Activity Impairment (WPAI) in patients with psoriatic arthritis (PsA) in real-world settings in Japan.MethodsThis 24-week, single-arm, postmarketing surveillance study (2014 –2017), conducted at 75 centers in Japan, enrolled adalimumab-naïve patients (paid workers, including part-time) meeting ClASsification criteria for Psoriatic ARthritis (CASPAR). The primary endpoint was improvement in overall work impairment (OWI) scores from baseline to week 24. Secondary endpo ints included changes in WPAI-PsA (OWI, absent...
Source: Advances in Therapy - January 19, 2019 Category: Drugs & Pharmacology Source Type: research

Continuous Glucose Monitoring: A Brief Review for Primary Care Practitioners
AbstractGlycated hemoglobin A1c (HbA1c) is routinely used as a marker of average glycemic control, but it fails to provide data on hypoglycemia and glycemic variability, both of which are associated with adverse clinical outcomes. Self-monitoring of blood glucose (SMBG), particularly in insulin-treated patients, is a cornerstone in the management of patients with diabetes. SMBG helps with treatment decisions that aim to reduce high glucose levels while avoiding hypoglycemia and limiting glucose variability. However, repeated SMBG can be inconvenient to patients and difficult to maintain in the long term. By contrast, conti...
Source: Advances in Therapy - January 18, 2019 Category: Drugs & Pharmacology Source Type: research

Clinical Outcomes, Treatment Patterns, and Health Resource Utilization Among Metastatic Breast Cancer Patients with Germline BRCA1/2 Mutation: A  Real-World Retrospective Study
AbstractIntroductionWith evolving treatment guidelines for germlineBRCA1/2 mutation (gBRCAm) in breast cancer, we present the latest gBRCA testing rates among metastatic breast cancer (mBC) patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2 −) or triple-negative breast cancer (TNBC). Among these patients with gBRCAm, we analyzed clinical outcomes, treatment patterns, and health resource utilization (HRU).MethodsThe Flatiron Health electronic health record database was used to assess gBRCA testing rates in a real-world retrospective analysis of US patients at least 18 &...
Source: Advances in Therapy - January 17, 2019 Category: Drugs & Pharmacology Source Type: research

Long-Term Efficacy of Tumor Necrosis Factor Inhibitors for the Treatment of Methotrexate-Na ïve Rheumatoid Arthritis: Systematic Literature Review and Meta-Analysis
ConclusionIn double-blind studies, 2-year efficacy outcomes were significantly improved with first-line TNFi versus other treatment strategies in patients with MTX-na ïve RA. No significant differences in these outcomes were observed when data from open-label RCTs were considered on their own. Further data on the efficacy of TNFi therapy over ≥ 2 years in patients with methotrexate-naïve RA are required.Plain Language SummaryPlain language summary available for this article. (Source: Advances in Therapy)
Source: Advances in Therapy - January 12, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Multicenter, Randomized, Controlled Study Comparing Tafluprost/Timolol Fixed Combination with Latanoprost/Timolol Fixed Combination in Primary Open-Angle Glaucoma and Ocular Hypertension
In the original publication, the range to derive the P values is incorrectly represented in Table  2 and Table 3. The corrected tables are provided below. (Source: Advances in Therapy)
Source: Advances in Therapy - January 8, 2019 Category: Drugs & Pharmacology Source Type: research